A new drug combination aimed at patients with chronic lymphocytic leukaemia (CLL) has been shown to improve progression-free survival (PFS) compared with chemotherapy alone.
The phase III study, REACH, looked at Rituxan (rituximab) in combination with fludarabine and cyclophosphamide chemotherapy in patients with previously treated CD20-positive CLL.
The study reported no new or unexpected safety signals, and an independent review of the primary endpoint is now being conducted for US regulatory purposes.
Earlier this year, another European phase III study, CLL-8, showed that a similar treatment combination improved PFS in patients with CLL who had not previously received treatment.
Hal Barron, senior vice-president of the drug’s maker, Genentech, said: “REACH, the largest relapsed CLL trial ever conducted, is the first phase III study of this treatment combination to show an improvement in progression-free survival for patients.
“We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”
Biogen’s president of research and development, Cecil Pickett, added: “Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy.
“The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication.”
Copyright PA Business 2008